Michigan-made BioThrax remains only anthrax vaccine

Ten years later, drug has no licensed competitor in sight.

Emergent BioSolutions Vice President Dino Muzzin holds a product sample of BioThrax, the only FDA-licensed vaccine available for pre-exposure protection against anthrax infection, that is produced in his manufacturing plant in Lansing, Mich.(Photo: Ryan Garza, Detroit Free Press)

Story Highlights

BioThrax's maker plans a new facility in Lansing, Mich., to expand production

There were early concerns about Biothrax's side effects

Emergent BioSolutions has a $1.25 billion deal to supply 45 million doses of BioThrax to the federal government

WASHINGTON — Ten years ago, the nation's only licensed anthrax vaccine looked to be on the way out, plagued by concerns over its side effects, cost and a dosing schedule some thought too long to be effective in a bioterror attack.

Military personnel required to get it complained loudly. Congress questioned its efficacy. The prestigious Institute of Medicine called for a better vaccine and hundreds of millions of dollars were committed to make one.

Fast-forward a decade or so later, however, and it's still that first vaccine — BioThrax, still made in a formerly state-owned lab in Lansing — that remains the only of its kind licensed for use, with no clear competitor in sight.

It's done so well that its maker, Rockville, Md.-based Emergent BioSolutions, is preparing to open a new Lansing facility to more than double production — and has a $1.25 billion deal to supply 45 million doses to the federal government.

"The reality is that BioThrax is the gold standard for anthrax vaccinations," said CEO and President Daniel Abdun-Nabi. "The last challenge ... is to provide large-scale production. ... That's what Building 55 is designed to do."

That's not how it looked in the late 1990s and early 2000s, however.

Worries about side effects — headaches, dizziness, flu-like symptoms and more — and a dosing schedule that included six shots over 18 months and annual boosters thereafter, had critics clamoring for a new inoculation.

But a rival vaccine, initially provided an $877 million federal government award, fell through. And a program requiring military personnel to get the shots, which had been suspended, was reinstated after the Food and Drug Administration declared BioThrax safe.

And though some complained Emergent BioSolutions used heavy-handed corporate tactics and aggressive lobbying to sink its competitors, persistent concerns about a bioterror attack led to more than $1 billion in sales.

Much of that went to the Strategic National Stockpile, a warehousing of drugs to be used in case of widespread attack. Meanwhile, in the intevening decade, many concerns were addressed. BioThrax, based on science from the '50s, was more adaptable and effective than originally known.

Researchers found that, by injecting the vaccine into muscle, side effects were reduced. Shelf life turned out to be longer than originally believed. And while the FDA-approved dosing schedule is now five doses over 18 months with boosters, the Centers for Disease Control and Prevention in Atlanta says a three-dose series over six months may provide adequate protection for up to three years — a finding that could lead to changes in the FDA-approved schedule.

"This vaccine had this bad reputation. ... People didn't want to get it," said Conrad Quinn, who has been part of research into the vaccine at the CDC. "We know now that this vaccine is as safe as any of the other vaccines of its type. ... It works better than credit was given in the '70s, '80s and '90s."

Reversal of fortunes

It could take until 2014 or 2015 until the new Lansing facility, already several years old, completes a meticulous FDA going-over and receives certification. But it's still a measure of the turnaround in fortunes for BioThrax.

For a time, the government wanted the new facility to produce a different vaccine, one that might result in fewer doses or be less expensive — BioThrax has typically run about $21 to $28 a dose. But it has since changed direction.

Emergent BioSolutions Vice President Dino Muzzin stands near the water port injection and purifying water systems storage facility in the process utilities room on Thursday Aug. 15, 2013, that is part of the life blood of the manufacturing plant that produces the only FDA-licensed vaccine available for pre-exposure protection against anthrax infection out of the business in Lansing, Mich.(Photo: Ryan Garza, Detroit Free Press)

While the government is still looking for, and investing in, a next-generation anthrax vaccine, BioThrax itself, when mixed with another agent, may be that sought-after inoculation. In the meantime, the U.S. government has committed up to $107 million to help open the facility.

Even as Emergent BioSolutions readies its facility to boost production from 9 million doses a year to 20 million-25 million, BioThrax still has its skeptics.

Dr. D.A. Henderson, a public health expert who led the effort to eradicate smallpox in the 1970s and served as director of the Office of Public Health Emergency Preparedness, questioned why the U.S. is stockpiling a vaccine that still requires multiple doses to be deployed in a very short window.

"It's been 11 or 12 years and we're still sitting with the same vaccine that was pretty much worked up in the 1950s," he said. "If we have an outbreak today in Detroit, we can hand out antibiotics. Would we vaccinate people? How many health commissions can vaccinate an entire city ... within a day? Can anybody do it? Absolute nobody."

Retired Air Force Col. Randall Larsen, who was director of a congressional commisson on weapons of mass destruction, said the answer is simple enough: For now, it's the only available option.

"I would like a single-dose vaccine ... to last my whole lifetime," he said. "We don't have that kind of vaccine. Even if the president said, 'let's go do it today,' it would probably take 10 years to develop."

Potential weapon

BioThrax traces its roots to a time when the State of Michigan made its own vaccines and produced an anthrax drug to prevent those susceptible — mainly workers in wool mills and tanneries — from being infected.

Naturally occurring, anthrax spores can enter the body through a cut, by ingestion or by inhalation. Changes in industrial practices, however, have largely eradicated infections.

But anthrax has long been considered a potential weapon, because when inhaled the fatality rate for untreated anthrax is 75%. No large-scale attack has ever been mounted, but experts consider the threat a real one.

Some skeptics, like Barbara Loe Fisher, president of the National Vaccine Information Center, wonder whether billions spent on vaccines are justified.

"Where is the evidence there are any terrorists in any country that have the capability to weaponize anthrax and successfully deliver it?" she asked.

But officials say they have that justification, even if it is classified: In 2001, five people died in the anthrax-letter attacks in the U.S. and, as recently as last year, a federal planning document said without preparations, an attack "could leave an untold number of Americans dead or permanently disabled."

In July, House Intelligence Chairrman Mike Rogers, R-Howell, wrote House and Senate appropriators asking that they ensure funding for stockpiling and developing vaccines be protected through Sept. 30, the end of the fiscal year, saying there remains "real and imminent threats."

Anthrax "is your No. 1 threat organism," said Jeffrey Adamovicz, a research microbiologist at the Wyoming State Veterinary Lab and a former chief bacteriologist in the Army's infectious disease lab in Maryland.

BioThrax is licensed only for use pre-exposure: Its maker has been seeking licensure as a post-exposure vaccine for years. But it has been used post-exposure in emergencies, such as the 2001 attacks, to counteract spores not neutralized by antibiotics.

A milky-white liquid made from filtered cultures of a harmless strain of anthrax, BioThrax stimulates the immune system to produce antibodies that block a protein anthrax creates, neutralizing its toxins.

"If you're smart enough to make a good anthrax weapon, you're probably smart enough to make it resistant to our antibiotics," said Larsen. "But the vaccine would still work."

Target of criticism

Emergent BioSolutions, formerly BioPort, has been a target of criticism ever since the company, founded by Fuad El-Hibri and other investors, including the late Adm. William Crowe, a former Joint Chiefs of Staff chairman, bought the lab in 1998.

Military personnel filed lawsuits against the mandatory inoculations. And in 2004, the federal government awarded a California firm, VaxGen, $877 million for 75 million doses of a newer vaccine to be available within two years.

By late 2006, VaxGen's contract was voided for missing deadlines, costing the government about $2 million. But critics questioned whether Emergent BioSolutions' lobbying — it has spent more than $20 million since 2005 — and connections played a role.

"They had a monopoly and when there was an R&D effort to move to a second-generation product that threatened it, they responded by enormous lobbying," said Dr. Phillip K. Russell, a vaccine expert and veteran of the Army Medical Corps who led the effort to stockpile vaccines after the 2001 anthrax attacks.

The U.S. General Accounting Office said VaxGen's vaccine was not ready for large-scale development in a two-year time frame. In 2007, Emergent got a deal to supply 18.75 million doses of BioThrax to the stockpile and went on to buy out VaxGen.

"I think the important thing to remember is no amount of lobbying and no amount of time with government officials changes the science," said Abdun-Nabi. "The science is the science."

The U.S. still wants a next-generation vaccine. A report last December projected one could be available by no later than 2017, and in recent years, the government has spent at least $600 million, if not more, on anthrax research. Someday, a single-dose vaccine — one that might be inhaled, say — could be developed.

But for now, BioThrax will remain a significant part of the stockpile, said Robin Robinson, director of the federal Biomedical Advanced Research and Development Authority, part of the Department of Health and Human Services.

"It's an insurance policy," Robinson said of BioThrax. "We don't know if these other vaccines are going to work."